Prostate Cancer Clinical Trial

Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Summary

This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. Determine the number of patients with a > 50% decrease in prostate-specific antigen (PSA) of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 (eribulin mesylate).

SECONDARY OBJECTIVES:

I. Estimate the measurable disease response in patients with measurable disease.

II. Determine the duration of PSA and measurable disease response.

III. Characterize the safety and tolerability of E7389 in these patients.

OUTLINE:

This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received. The 3 cohorts are chemonaive stratum, prior-taxane stratum, and two-prior-chemotherapy stratum. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Progressive metastatic disease or stable metastatic disease with rising PSA
Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure
Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment
Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks
ECOG performance status 0-2
Adequate bone marrow function
Bilirubin =< 1.5 mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min
Fertile patients must use effective contraception
A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression
At least 4 weeks since prior chemotherapy or radiotherapy
At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression
Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy)
More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids)
Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression

Exclusion Criteria:

Active angina pectoris
Known New York Heart Association class III-IV heart disease
Myocardial infarction within the past 6 months
Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint)
Peripheral neuropathy > grade 2
Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years
Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4
More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents
Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy
Concurrent palliative radiotherapy
Concurrent estrogen, estrogen-like agents, or any other hormonal therapy
Carcinomatous meningitis or brain metastases
Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes
Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT00337077

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 118 Locations for this study

See Locations Near You

Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
Community Hospital of Monterey Peninsula
Monterey California, 93940, United States
Manchester Memorial Hospital
Manchester Connecticut, 06040, United States
Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital Association
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Mercy Hospital and Medical Center
Chicago Illinois, 60616, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Sherman Hospital
Elgin Illinois, 60123, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Evanston CCOP-NorthShore University HealthSystem
Evanston Illinois, 60201, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Illinois CancerCare Galesburg
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates Limited
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
Mcdonough District Hospital
Macomb Illinois, 61455, United States
Garneau, Stewart C MD (UIA Investigator)
Moline Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline Illinois, 61265, United States
Sharis, Christine M MD (UIA Investigator)
Moline Illinois, 61265, United States
Stoffel, Thomas J MD (UIA Investigator)
Moline Illinois, 61265, United States
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
Moline Illinois, 61265, United States
Bromenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center Foundation
Normal Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa Illinois, 61350, United States
Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Pekin Hospital
Pekin Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61603, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Edward H Kaplan MD and Associates
Skokie Illinois, 60076, United States
Saint Margaret's Hospital
Spring Valley Illinois, 61362, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Clinic-Urbana Main
Urbana Illinois, 61801, United States
Carle Foundation - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Community Howard Regional Health
Kokomo Indiana, 46904, United States
Indiana University Health La Porte Hospital
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Center
Michigan City Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46601, United States
McFarland Clinic
Ames Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf Iowa, 52722, United States
Cedar Rapids Oncology Association
Cedar Rapids Iowa, 52403, United States
Mercy Hospital
Cedar Rapids Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Mercy Capitol
Des Moines Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Iowa Oncology Research Association CCOP
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Hematology Oncology Associates
Sioux City Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Eastern Cooperative Oncology Group
Boston Massachusetts, 02215, United States
Bixby Medical Center
Adrian Michigan, 49221, United States
Hickman Cancer Center
Adrian Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor Michigan, 48106, United States
Oakwood Hospital
Dearborn Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba Michigan, 49431, United States
Hurley Medical Center
Flint Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Green Bay Oncology - Iron Mountain
Iron Mountain Michigan, 49801, United States
Allegiance Health
Jackson Michigan, 49201, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital
Monroe Michigan, 48162, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw Michigan, 48601, United States
Lakeland Hospital
St. Joseph Michigan, 49085, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji Minnesota, 56601, United States
Essentia Health Duluth Clinic CCOP
Duluth Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth Minnesota, 55805, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield Minnesota, 55355, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
Saint Joseph's Hospital - Healtheast
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Hunterdon Medical Center
Flemington New Jersey, 08822, United States
Hackensack University Medical CCOP
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey At Hamilton
Hamilton New Jersey, 08690, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly New Jersey, 08060, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Virtua West Jersey Hospital Voorhees
Voorhees New Jersey, 08043, United States
The North Division of Montefiore Medical Center
Bronx New York, 10466, United States
New York University Langone Medical Center
New York New York, 10016, United States
Sanford Clinic North-Fargo
Fargo North Dakota, 58122, United States
Sanford Medical Center-Fargo
Fargo North Dakota, 58122, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green Ohio, 43402, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
North Coast Cancer Care-Clyde
Clyde Ohio, 43410, United States
Hematology Oncology Center Incorporated
Elyria Ohio, 44035, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Toledo Clinic Cancer Centers-Maumee
Maumee Ohio, 43537, United States
Saint Luke's Hospital
Maumee Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee Ohio, 43537, United States
Saint Charles Hospital
Oregon Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon Ohio, 43616, United States
North Coast Cancer Care
Sandusky Ohio, 44870, United States
Flower Hospital
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
University of Toledo
Toledo Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo Ohio, 43617, United States
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Saint Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Lewistown Hospital
Lewistown Pennsylvania, 17044, United States
Mount Nittany Medical Center
State College Pennsylvania, 16803, United States
Fredericksburg Oncology Inc
Fredericksburg Virginia, 22401, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
UW Health Oncology - 1 South Park
Madison Wisconsin, 53715, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Green Bay Oncology - Oconto Falls
Oconto Falls Wisconsin, 54154, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States
Riverview Hospital
Wisconsin Rapids Wisconsin, 54494, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

121

Study ID:

NCT00337077

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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